APPLICATION
ANDA062206
TYPE
ANDA
ORIGINAL APPROVAL
1979-04-23
LATEST ACTION
2000-03-27
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued
Products
CEFACLORDiscontinued
CEFACLOR EQ 187MG BASE/5ML · FOR SUSPENSION · ORAL
CEFACLORDiscontinued
CEFACLOR EQ 125MG BASE/5ML · FOR SUSPENSION · ORAL
CEFACLORDiscontinued
CEFACLOR EQ 375MG BASE/5ML · FOR SUSPENSION · ORAL
CEFACLORDiscontinued
CEFACLOR EQ 250MG BASE/5ML · FOR SUSPENSION · ORAL
Approval history
2000-03-27Manufacturing (CMC) · Supplement 52AP
2000-02-15Manufacturing (CMC) · Supplement 50AP
2000-02-15Manufacturing (CMC) · Supplement 51AP
1999-12-20Manufacturing (CMC) · Supplement 49AP
1999-08-30Labeling · Supplement 48AP
1998-09-30Labeling · Supplement 46AP
1997-10-23Labeling · Supplement 47AP
1997-04-01Labeling · Supplement 43AP
1996-11-13Manufacturing (CMC) · Supplement 44AP
1996-06-10Labeling · Supplement 38AP
1996-05-10Labeling · Supplement 40AP
1994-07-13Labeling · Supplement 33AP
1994-06-23Manufacturing (CMC) · Supplement 37AP
1994-06-02Labeling · Supplement 34AP
1994-05-24Labeling · Supplement 29AP
1993-04-27Manufacturing (CMC) · Supplement 36AP
1993-04-27Manufacturing (CMC) · Supplement 35AP
1993-01-07Manufacturing (CMC) · Supplement 32AP
1992-08-31Manufacturing (CMC) · Supplement 25AP
1991-08-12Manufacturing (CMC) · Supplement 23AP
1989-01-26Manufacturing (CMC) · Supplement 18AP
1988-04-20Manufacturing (CMC) · Supplement 14AP
1979-04-23OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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